SYNTHETIC CHEMISTRY SERVICES

For Bionalytical Support

Custom Synthesis of Drug Metabolites

When a drug is administered to an organism, it is subject to modification by enzymes resulting in the production of metabolites from the original parent drug. Drug metabolism can result in the formation of toxic or pharmacologically active chemicals. Accordingly, regulatory agencies require testing of drug metabolites and the evaluation of their safety in clinical research. Testing of drug metabolites requires the synthesis of adequate amounts of the metabolite (milligram to gram quantities) in order to support testing.

AptoChem has an extensive in-house library of APIs and metabolites. For a complete listing, please visit our Products page. If you cannot find what you are looking for, please request a quotation, including all relevant information and one of our scientists will respond within 24 hours. Discounts are available for volume orders and for the purchase of a family of products (API and metabolites). Please contact us for more details or read or radiolabeled test article page.

Custom Synthesis of Isotopically Labeled Reference Standards

Isotopically labeled reference standards are used as internal standards in bioanalytical mass spectrometry. Isotopically labeled reference standards possess the same physico-chemical properties as the unlabeled version, differing only in a higher molecular weight. Using isotopically labeled reference standards from AptoChem will simplify method development and validation, reduce R&D costs, improve method robustness and lower costs of sample analysis.

Our scientists label drugs and drug metabolites with sufficient deuteriums, at optimal molecular positions, to obtain the ideal deuterated internal standards. In cases where deuterium labeling is not feasible, we rely on ¹³C and ¹⁵N labeling. AptoChem has an extensive in-house library of isotopically labeled reference standards. For a complete listing, please visit our Products page. If you cannot find what your are looking for, please request a quotation, including all relevant information, and one of our scientists will respond within 24 hours. Discounts are available for volume orders and for the purchase of a family of internal standards. Please contact us for more details.

For Preclinical and DMPK Support

Custom Synthesis of Radiolabeled Test Articles

In order to evaluate the pharmacodynamic and pharmacokinetic profile of an investigational drug substance, DMPK studies in animals are conducted using a radiolabeled version of the drug. AptoChem is a leading company in the synthesis of ¹⁴C radiolabeled compounds. Our team of scientists work from our state-of-the art facility and understand that optimized ¹⁴C labeling is critical to the success of your pharmacokinetic studies and will introduce the ¹⁴C label at the optimal location, with sufficient specific activity, on the investigational drug substance to guarantee stability during the metabolism process. In addition, AptoChem can synthesize a stable isotope labeled version of the investigational drug at nominal charge.

To obtain a quotation, please send us a request including all relevant information, and one of our scientists will respond within 24 hours or contact us to discuss your specific requirements.

ANALYTICAL SERVICES

Are you purchasing poorly characterized and unsupported reference standards? You no longer need to settle. At AptoChem, quality is paramount and cGLP regulations are strictly adhered to. Our Analytical Services department is an essential quality control element in the synthetic process and provides complete chemical characterization of every reference standard that we sell. With our complete certification, you can be assured of the authenticity and purity of AptoChem reference standards. AptoChem's Certificate of Analysis details all of the testing performed on the product and is your evidence of compliance and quality. See an example of our Certificate of Analysis.

AptoChem also offers analytical testing as a stand alone service for organizations that do not have their own analytical resources or who have acquired inadequately characterized reference standards, and wish to have them characterized, tested and certified in accordance with cGLP regulations. The AptoChem team has extensive knowledge and expertise in chemical characterization, impurity isolation and characterization, method development and validation. In addition, we are licensed to handle radioactive test articles.

We currently offer several value added certification packages. Also, discounts are available for high volume analyses. Please visit the Analytical Services section in our Products page for complete details.

In addition, individual services are also offered:

·         NMR
·         Mass Spectrometry
·         Isotopic Distribution Calculations
·         HPLC Purity Profiling (UV-PDA)
·         Water Content (Karl Fischer)
·         Residual Solvent Content
·         Ion/Metal/Salt Content
·         Optical Rotation
·         HPLC Purity Profiling (Radiometric)
·         Specific Activity Determination

NMR SERVICES

·         ¹H-NMR
·         ¹H-NMR with D₂O exchange
·         COSY-NMR
·         ¹⁹F-NMR
·         ³¹P-NMR
·         ¹³C-NMR
·         APT-NMR
·         DEPT-NMR
·         HETCOR-NMR
·         NOESY NMR
·         CUSTOM NMR experiments

MASS SPECTROMETRY SERVICES

·         MS
·         MS/MS
·         Isotopic Distribution

CHROMATOGRAPHY SERVICES

·         HPLC Purity Profiling (UV-PDA)
·         HPLC Purity Profiling (UV-PDA + Radiometric)
·         Chiral HPLC Purity Profiling (UV-PDA)
·         Analytical Method Development and Validation

For a complete listing of analytical tests offered, please visit the Analytical Services section in our Products page. For any special testing that you may require, please contact us to discuss your needs.